Multiple Sclerosis Clinical Trial
— OPTIMUM-LTOfficial title:
Multicenter, Non-comparative Extension of Study AC-058B301, to Investigate the Long-term Safety, Tolerability, and Control of Disease of Ponesimod 20 mg in Subjects With Relapsing Multiple Sclerosis
Verified date | February 2024 |
Source | Actelion |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study AC-058B301 (OPTIMUM; NCT02425644) has been designed to investigate the efficacy, safety and tolerability of ponesimod in subjects with relapsing multiple sclerosis (RMS). The AC-058B303 study is the long-term extension for the core study AC-058B301. The purpose of this long term extension of the core study AC-058B301 is to characterize the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with RMS.
Status | Completed |
Enrollment | 877 |
Est. completion date | January 16, 2024 |
Est. primary completion date | January 16, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Signed informed consent 2. Subjects with MS having completed the double-blind treatment in the core study as scheduled 3. Compliance with teriflunomide elimination procedure 4. Women of childbearing potential (WOCBP) must have a negative pre-treatment urine pregnancy test, must agree to undertake 4-weekly urine pregnancy tests, and must have been using reliable methods of contraception. Fertile male subjects participating in the study must agree to use a condom. Exclusion Criteria: 1. Any of the following cardiovascular conditions on Day 1 pre-dose: 1. Resting heart rate (HR) < 50 bpm; 2. Presence of second degree atrioventricular (AV) block or third degree AV block or a QTcF interval > 470 ms (females), > 450 ms (males); 2. Any of the following alerts from central laboratory at Visit 14 of the core study (EOT) which was confirmed as an alert at repeated testing or not repeated prior to FU1 of the core study: 1. Lymphocyte count: < 0.2 x 109/L; 2. Neutrophil count <1.0 × 109/L; 3. Platelet count < 50 × 109/L; 4. Creatinine clearance < 30 mL/min 3. At Visit 14 of the core study (EOT) >30% decrease from core study baseline FEV1 and/or FVC; 4. Clinically significant, persistent respiratory AEs (e.g., dyspnea) not resolved prior to first dosing in the extension study. 5. Macular edema at any time between Visit 1 (Screening) in the core study and Day 1 of the extension study. 6. Presence of the following at core study Visit 14 (EOT, Week 108), FU1, or abbreviated visit FU2, or on Day 1 of the extension study pre-dose: 1. Suspected opportunistic infection of the CNS or any other infection which, in the opinion of the investigator, contraindicates re-start of the study drug; 2. Stevens-Johnson syndrome or toxic epidermal necrolysis or drug reaction with eosinophilia and systemic symptoms. 7. Need for and intention to administer forbidden study treatment-concomitant therapy 8. Women who are pregnant or lactating. 9. Male subjects wishing to parent a child; 10. Treatment with any MS Disease Modifying Therapies; 11. Any other clinically relevant medical or surgical condition, which, in the opinion of the investigator, would put the subject at risk by participating in the study; 12. Subjects unlikely to comply with the extension study protocol based on investigator best judgment |
Country | Name | City | State |
---|---|---|---|
Belarus | Grodno University Hospital | Grodno | |
Belarus | Minsk City Clinical Hospital 5 | Minsk | |
Belarus | Republican Scientific Clinical Centre | Minsk | |
Belarus | Vitebsk Regional Clinical Hospital | Vitebsk | |
Belarus | Vitebsk Regional Diagnostic Center | Vitebsk | |
Bosnia and Herzegovina | University Clinicl Center Sarajevo | Sarajevo | |
Bulgaria | UMHAT Sveti Georgi | Plovdiv | |
Bulgaria | Acibadem City Clinic Tokuda Hospital | Sofia | |
Bulgaria | Military Medical Academy, Multiprofile Hospital for Active Treatment -Sofia | Sofia | |
Bulgaria | Multiprofile Hospital for Active Treatment in Neurology and Psychiatry Sveti Naum | Sofia | |
Bulgaria | Multiprofile Hospital For Active Treatment National Cardiology Hospital, Ead | Sofia | |
Bulgaria | St Ivan Rilski University Multiprofile Hospital For Active Treatment | Sofia | |
Bulgaria | University Multiprofile Hospital for Active Treatment Alexandrovska EAD | Sofia | |
Canada | University of Alberta | Edmonton | Alberta |
Canada | Recherche Sepmus Inc. | Greenfield Park | Quebec |
Canada | Ottawa Hospital | Ottawa | Ontario |
Canada | Royal Jubilee Hospital | Victoria | British Columbia |
Croatia | Ch Osijek | Osijek | |
Croatia | University Hospital Center Zagreb | Zagreb | |
Czechia | Fakultní nemocnici Brno | Brno | |
Czechia | Fakultni nemocnice Hradec Kralove | Hradec Králové | |
Czechia | Nemocnice Jihlava | Jihlava | |
Czechia | Fakultni nemocnice Ostrava | Ostrava-Poruba | |
Czechia | Pardubicka krajska nemocnice a.s. | Pardubice | |
Czechia | Vseobecna Fakultní Nemocnice | Praha 2 | |
Czechia | FN Motol | Praha 5 | |
Czechia | Krajska zdravotni, a.s. - Nemocnice Teplice, o.z. | Teplice | |
Finland | Suomen Terveystalo Tampere | Tampere | |
Finland | Mehilainen NEO | Turku | |
France | Hopital Pellegrin CHU Bordeaux | Bordeaux cedex | |
France | CHU Clermont-Ferrand - Hopital Gabriel Montpied | Clermont Ferrand Cedex 1 | |
France | Hôpital Nord Laennec - CHU NANTES | Nantes Cedex 1 | |
France | Hopital PASTEUR | Nice | |
France | Nouvel Hopital Civil | Strasbourg CEDEX | |
Georgia | LTD 'Aversi Clinic' | T'bilisi | |
Georgia | Curatio, Jsc | Tbilisi | |
Georgia | P. Sarajishvili Institute of Neurology | Tbilisi | |
Georgia | Pineo Medical Ecosystem Ltd | Tbilisi | |
Georgia | S.Khechinashvili University Hospital | Tbilisi | |
Germany | Universitätsklinikum Carl-Gustav-Carus Dresden | Dresden | |
Germany | Helios Klinikum Erfurt | Erfurt | |
Germany | Panakeia - Arzneimittelforschung GmbH | Leipzig | |
Germany | Universitätsmedizin der Johannes Gutenberg-Universität Mainz | Mainz | |
Greece | 401 Military Hospital | Athens | |
Greece | Naval Hospital of Athens | Athens | |
Greece | Medical Center of Athens | Marousi | |
Hungary | Jahn Ferenc Del-pesti Korhaz es Rendelointezet | Budapest | |
Hungary | Uzsoki Utcai Korhaz | Budapest | |
Hungary | Valeomed EGÉSZSÉGÜGYI KÖZPONT | Esztergom | |
Hungary | Petz Aladar Megyei Oktato Korhaz | Gyor | |
Hungary | Pest Megyei Flor Ferenc Korhaz | Kistarcsa | |
Israel | Barzilai Medical Center | Ashkelon | |
Israel | Rambam Medical Center | Haifa | |
Israel | Hadassah Medical Center | Jerusalem | |
Israel | Ziv Medical Center | Safed | |
Italy | Ospedale San Salvatore | L' Aquila | |
Italy | Azienda Ospedaliera Sant Andrea | Roma | |
Latvia | Latvias Juras medicinas centrs Ltd | Riga | |
Latvia | Pauls Stradins Clinical University Hospital | Riga | |
Latvia | Rigas Austrumu kliniska universitates slimnica | Riga | |
Lithuania | VsI Respublikine Siauliu ligonine, V. | Šiauliai | |
Lithuania | Hospital of Lithuanian University of Health Sciences Kaunas Clinics | Kaunas | |
Mexico | Unidad de Investigacion En Salud | Chihuahua | |
Mexico | CRI Centro Regiomontano de Investigacion SC | Nuevo Leon | |
Poland | Neurocentrum Bydgoszcz Sp Z O O | Bydgoszcz | |
Poland | Copernicus Podmiot Leczniczy Sp. z o.o | Gdansk | |
Poland | NEURO-MEDIC Janusz Zbrojkiewicz Poradnia Wielospecjalistyczna | Katowice | |
Poland | NeuroCentrum. Centrum Terapii SM | Katowice | |
Poland | Centrum Kompleksowej Rehabilitacji | Konstancin-Jeziorna | |
Poland | Centrum Opieki Zdrowotnej Orkan-Med | Ksawerow | |
Poland | Indywidualna Praktyka Lekarska Prof. Konrad Rejdak | Lublin | |
Poland | Clinical Research Center sp. z o.o MEDIC-R s.k. | Poznan | |
Poland | NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partnerska Lekarzy | Poznan | |
Poland | Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Po | Poznan | |
Poland | WroMedica I.Bielicka, A.Strzalkowska s.c. | Wroclaw | |
Portugal | Hospital de Braga | Braga | |
Portugal | Hospitais da universidade de Coimbra | Coimbra | |
Portugal | Hosp. Cuf Descobertas | Lisboa | |
Portugal | H. Santo António - Centro Hospitalar do Porto | Porto | |
Romania | Institutul Clinic Fundeni | Bucuresti | |
Romania | Spitalul Universitar de Urgenta Bucuresti | Bucuresti | |
Romania | Spitalul Universitar de Urgenta Militar Central 'Dr. Carol Davila' | Bucuresti | |
Romania | Spitalul Clinic Judetean de Urgenta 'Pius Brinzeu' | Timisoara | |
Russian Federation | Barnaul Territorial Clinical Hospital | Barnaul, Altai Krai | |
Russian Federation | St. Joseph Belgorod Regional Hospital | Belgorod | |
Russian Federation | Bryansk Regional Hospital #1 | Bryansk | |
Russian Federation | Sverdlovsk Region Clinical Hospital #1 | Ekaterinburg | |
Russian Federation | Research Medical Center Your Health | Kazan | |
Russian Federation | Federal State Budgetary Institution | Krasnoyarsk | |
Russian Federation | State Budgetary Healthcare Institution Kursk Region Kursk Regional Clinical Hospital | Kursk | |
Russian Federation | Central Clinical Hospital N.A.Semashko | Moscow | |
Russian Federation | Clinical City Hospital #1 | Moscow | |
Russian Federation | State Health Care Institution Of Moscow | Moscow | |
Russian Federation | Municipal Clinical Hospital # 3 | Nizhniy Novgorod | |
Russian Federation | Siberian District Medical Center of Federal Medical-Biological Agency | Novosibirsk | |
Russian Federation | Federal Scientific Clinical Center of Physico-Chemical Medicine | Odintsovo | |
Russian Federation | Perm State Medical Academy n.a. E. A. Vagner | Perm | |
Russian Federation | City Clinical Hospital # 2 | Pyatigorsk | |
Russian Federation | Pavlov First Saint Petersburg State Medical University | Saint Petersburg | |
Russian Federation | State Healthcare Institution Samara Regional Clinical Hospital named after V.D.Seredavin | Samara | |
Russian Federation | Smolensk Regional Clinical Hospital | Smolensk | |
Russian Federation | City Clinical Hospital #31 | St. Petersburg | |
Russian Federation | Institute of Human Brain Ras | St. Petersburg | |
Russian Federation | Municipal Multi-Specialty Hospital # 2 | St. Petersburg | |
Russian Federation | City Hospital# 40 | St.Petersburg | |
Russian Federation | Siberian State Medical University | Tomsk | |
Russian Federation | Tver Regional Clinical Hospital | Tver | |
Russian Federation | GUZ Novgorod Regional Clinical Hospital | Velikiy Novgorod | |
Russian Federation | Yaroslavl Clinical Hospital #8 | Yaroslavl | |
Serbia | Clinical Hospital Center Zvezdara | Belgrade | |
Serbia | Vojnomedicinska Akademija | Belgrade | |
Serbia | University Clinical Center Kragujevac | Kragujevac | |
Serbia | University Clinical Center NIS | Nis | |
Spain | Hospital Clinic I Provincial | Barcelona | |
Spain | Hospital del Mar | Barcelona | |
Spain | Hospital Vall d'Hebron | Barcelona | |
Spain | Hospital Universitario de La Princesa | Madrid | |
Spain | Hospital Regional Universitario de Malaga | Malaga | |
Spain | Hospital Universitario Virgen Macarena | Sevilla | |
Spain | Hospital Vithas Nisa Sevilla | Sevilla | |
Sweden | Sahlgrenska Universitetsjukhuset | Göteborg | |
Sweden | Centrum för Neurologi | Stockholm | |
Turkey | Karadeniz Teknik University Medical Faculty | Trabzon | |
Ukraine | Municipal health care institution Chernihiv Regional Hospital | Chernihiv | |
Ukraine | Public Non-profit Enterprise: Chernihiv City Hospital #4 under Chernihiv City Council | Chernihiv | |
Ukraine | Ivano-Frankivsk Regional Clinical Hospital | Ivano-Frankivsk | |
Ukraine | Limited Liability Company 'Neuro Global' | Ivano-Frankivsk | |
Ukraine | Kharkiv Postgrad Academy, Dept of Neurology #1 At Hosp #7 | Kharkiv | |
Ukraine | Kharkiv Railway Clinical Hospital N1 Of Brance 'Health Center' | Kharkiv | |
Ukraine | National Research Center for Radiation Medicine | Kyiv | |
Ukraine | Lviv Clinical Regional Hospital | Lviv | |
Ukraine | Public Non-Profit Enterprise: Lviv City Clinical Hospital #5 | Lviv | |
Ukraine | Odessa National Medical University | Odesa | |
Ukraine | ME 'Poltava Regional Clinical Hospital n.a. M.V. Sklifosovsky of the Poltava Regional Council' | Poltava | |
Ukraine | Mnce 'Ternopil Regional Clinical Psychoneurology Hospital' of Trb | Ternopil | |
Ukraine | Medical Center Salutem LLC | Vinnytsia | |
Ukraine | O.F. Herbachevskyi Regional Clinical Hospital | Zhytomyr | |
United Kingdom | Royal Preston Hospital | Preston | |
United Kingdom | Salford Royal NHS Foundation Trust | Salford | |
United States | The Research Center of Southern California, LLC | Carlsbad | California |
United States | Ohio Health | Columbus | Ohio |
United States | Mountain View Clinical Research | Denver | Colorado |
United States | Advanced Neurosciences Institute | Franklin | Tennessee |
United States | Josephson Wallack Munshower Neurology, PC | Indianapolis | Indiana |
United States | Neurology Associates of Ormond Beach | Ormond Beach | Florida |
United States | The Neurology Group | Pomona | California |
United States | Raleigh Neurology Associates | Raleigh | North Carolina |
United States | University of South Florida | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Actelion |
United States, Belarus, Bosnia and Herzegovina, Bulgaria, Canada, Croatia, Czechia, Finland, France, Georgia, Germany, Greece, Hungary, Israel, Italy, Latvia, Lithuania, Mexico, Poland, Portugal, Romania, Russian Federation, Serbia, Spain, Sweden, Turkey, Ukraine, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Annualized confirmed relapse rate (ARR) | defined as the number of confirmed relapses per subject-year | Analysis period: From day 1 in core study (Enrollment) to end-of-treatment (EOT) in the extension study, i.e. for up to 354 weeks | |
Primary | Time from core study randomization to first confirmed relapse | Time from enrollment in core study to first confirmed relapse | Analysis period: From day 1 in core study (Enrollment) to end-of-treatment (EOT) in the extension study, i.e. for up to 354 weeks | |
Primary | Time to first 12-week confirmed disability accumulation (CDA) | Time from core baseline to first 12-week CDA | Analysis period: From day 1 in core study (Enrollment) to end-of-treatment (EOT) in the extension study, i.e. for up to 354 weeks | |
Primary | Time to first 24-week confirmed disability accumulation (CDA) | Time from core baseline to first 24-week CDA | Analysis period: From day 1 in core study (Enrollment) to end-of-treatment (EOT) in the extension study, i.e. for up to 354 weeks | |
Primary | Patients with absence of relapses | Number of patients with absence of relapses during study period | Analysis period: From day 1 in core study (Enrollment) to end-of-treatment (EOT) in the extension study, i.e. for up to 354 weeks | |
Primary | Change from baseline in Expanded Disability Status Scale (EDSS) | Change from baseline in EDSS at all assessments | Analysis period: From day 1 in core study (Enrollment) to end-of-treatment (EOT) in the extension study, i.e. for up to 354 weeks | |
Primary | Assessment of no evidence of disease activity (NEDA) status at end-of-study (EOS) according to NEDA 3 | NEDA 3 defined by the absence of confirmed relapse, GD+ T1 lesions, new or enlarging T2 lesions and 12-week CDA | Up to 354 weeks | |
Primary | Assessment of no evidence of disease activity (NEDA) status at EOS according to NEDA 4 | NEDA 4 defined by the absence of confirmed relapse, GD+ T1 lesions, new or enlarging T2 lesions and 12-week CDA, and annual brain volume change = -0.4% from baseline to all assessments | Up to 354 weeks | |
Primary | Percent change from baseline in brain volume (PCBV) measured by magnetic resonance imaging (MRI) | Change from baseline in brain volume at all assessments | Analysis period: From day 1 in core study (Enrollment) to end-of-treatment (EOT) in the extension study, i.e. for up to 354 weeks | |
Primary | Cumulative number of combined unique active lesions (CUAL) measured by MRI | Cumulative number of combined unique active lesions (CUAL) defined as new Gd+ T1 lesions plus new or enlarging T2 lesions (without double-counting the lesions) at all assessments | Analysis period: From day 1 in core study (Enrollment) to end-of-treatment (EOT) in the extension study, i.e. for up to 354 weeks | |
Primary | Determination of number of Gd+ T1 lesions by MRI | Number of Gd+ T1 lesions at all assessments | Analysis period: From day 1 in core study (Enrollment) to end-of-treatment (EOT) in the extension study, i.e. for up to 354 weeks | |
Primary | Cumulative number of new or enlarging T2 lesions measured by MRI | Cumulative number of new or enlarging T2 lesions (relative to baseline) at all assessments | Analysis period: From day 1 in core study (Enrollment) to end-of-treatment (EOT) in the extension study, i.e. for up to 354 weeks | |
Primary | Assessment of volume of brain lesions measured by MRI | Determination of MRI lesions (T2 lesions, T1 hypointense lesions) at all assessments | Analysis period: From day 1 in core study (Enrollment) to end-of-treatment (EOT) in the extension study, i.e. for up to 354 weeks | |
Primary | Absence of MRI lesions | Absence of MRI lesions (Gd+ T1 lesions, new or enlarging T2 lesions) at all assessments | Analysis period: From day 1 in core study (Enrollment) to end-of-treatment (EOT) in the extension study, i.e. for up to 354 weeks | |
Primary | Determination of proportion of Gd+ lesions at baseline evolving to persistent black holes (PBHs) | Proportion of Gd+ lesions at baseline evolving to PBHs at all assessments | Analysis period: From day 1 in core study (Enrollment) to end-of-treatment (EOT) in the extension study, i.e. for up to 354 weeks | |
Primary | Estimation of incidence rates of adverse events (AEs) | Incidence rates of treatment-emergent AEs, severe AEs, AEs of special interest and AEs leading to premature discontinuation of study treatment | Analysis period: From day 1 in core study (Enrollment) to end-of-treatment (EOT) in the extension study, i.e. for up to 354 weeks | |
Primary | Estimation of incidence rates of treatment-emergent morphological ECG abnormalities | ECG abnormalities as defined by the ECG provider | Analysis period: From day 1 in core study (Enrollment) to end-of-treatment (EOT) in the extension study, i.e. for up to 354 weeks | |
Primary | Assessment of cardiac rhythms measured by electrocardiogram (ECG) parameters | Absolute values by visit for 12-lead ECG parameters (HR, PR, QRS, QT, QTcB, QTcF) | Analysis period: From day 1 in core study (Enrollment) to end-of-treatment (EOT) in the extension study, i.e. for up to 354 weeks | |
Primary | Change from baseline values by visit for cardiac rhythms | Change from baseline values by visit for ECG parameters (HR, PR, QRS, QT, QTcB, QTcF) | Analysis period: From day 1 in core study (Enrollment) to end-of-treatment (EOT) in the extension study, i.e. for up to 354 weeks | |
Primary | Change in ECG parameters from pre-dose to selected post-dose assessments | Change in ECG parameters (HR, PR, QRS, QT, QTcB, QTcF) from pre-dose to selected post-dose assessments (1h, 2h, 3h, 4h) on day 1 of extension study and on day of re-initiation of study treatment | Analysis period: From day 1 in extension study to end-of-treatment (EOT) in extension study, i.e. for up to 240 weeks | |
Primary | Absolute values and percent change from baseline in forced expiratory volume and forced vital capacity | Absolute values and percent change from baseline in forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) at all assessments | Analysis period: From day 1 in core study (Enrollment) to end-of-treatment (EOT) in the extension study, i.e. for up to 354 weeks | |
Primary | Assessment of treatment-emergent decrease from baseline in forced expiratory volume and forced vital capacity | Determination of treatment-emergent decrease from baseline in FEV1 and FVC (absolute and % of predicted) | Analysis period: From day 1 in core study (Enrollment) to end-of-treatment (EOT) in the extension study, i.e. for up to 354 weeks | |
Primary | Absolute change from baseline to end-of-study (EOS) versus change from baseline to end-of-treatment (EOT) in forced expiratory volume and forced vital capacity | Absolute change from baseline to end-of-study (EOS) versus change from baseline to end-of-treatment (EOT) in FEV1 and FVC (absolute and % of predicted) | Analysis period: From day 1 in core study (Enrollment) to end-of-treatment (EOT) in the extension study, i.e. for up to 354 weeks |
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